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Procedure Kit (K926269)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K926269

by General Medical Co.

Identifiers

510(k) Number
K926269 FDA 510(k)
FDA Product Code
LRO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4370 FDA 510(k)
Regulation Number
878.4370 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SEKD FDA 510(k)

This device is a Procedure Kit (Product Code: LRO), designed for use in implant exposure and minor surgical procedures. It comprises sterile drapes, gowns, and protective covers intended to maintain a sterile field during procedures.

The kit is supplied as a sterile, single-use assembly and is intended for use in general and plastic surgery settings. Components include a wrapping sheet (100×100 cm), large surgical gowns with towels, a mini U-drape (50×80 cm), adhesive surface drapes (75×90 cm), and hose/tubing covers. Authorised under FDA 510(k) clearance K926269, it adheres to regulatory standards for surgical disposables.

Frequently asked questions

What types of surgical procedures is this Procedure Kit designed for, and why is it particularly useful in those settings?

This Procedure Kit is designed for implant exposure and minor surgical procedures, particularly in general and plastic surgery settings. It includes sterile drapes, gowns, and protective covers that help maintain a sterile field—critical for preventing infection during procedures where implants are exposed or small incisions are made. The combination of large gowns, mini drapes, and adhesive surface drapes ensures comprehensive coverage and barrier protection, reducing contamination risks in delicate or prolonged surgeries.

Is this Procedure Kit reusable, or is it meant for single-use only? How does that affect its use in a clinical setting?

This Procedure Kit is explicitly sterile and single-use only, as stated in the manufacturer’s description. This design choice is standard for surgical disposables to prevent cross-contamination between patients. Clinically, this means each kit must be opened only once and discarded after use, ensuring compliance with infection control protocols and eliminating the need for reprocessing or sterilization between procedures.

What are the key components included in this Procedure Kit, and how do they contribute to maintaining a sterile environment?

The kit includes a 100×100 cm wrapping sheet, large surgical gowns with towels, a 50×80 cm mini U-drape, 75×90 cm adhesive surface drapes, and hose/tubing covers. These components work together to create a comprehensive barrier system: the gowns and drapes isolate the surgical field from the patient’s body and surrounding environment, while the adhesive drapes secure the sterile field to the skin. The hose/tubing covers protect exposed medical lines from contamination, making it ideal for procedures involving implants or tubing.

How should this Procedure Kit be stored, and what precautions should be taken to ensure its sterility before use?

Since the kit is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer implies no additional sterilization is required—only that the seal remains intact until use. Clinicians should inspect the packaging for tears or damage before opening to confirm sterility, as compromised seals could compromise the sterile field during surgery.

What regulatory pathway was followed for this Procedure Kit’s approval, and what does that mean for its use in clinical practice?

This Procedure Kit was cleared through the FDA’s 510(k) process (K926269), a traditional pathway where the manufacturer demonstrates that it is substantially equivalent to a legally marketed predicate device. This means it has undergone FDA review for safety and effectiveness as a surgical disposable (Product Code LRO) and is authorized for use in general and plastic surgery settings. Clinicians can rely on its compliance with FDA standards for surgical drapes and gowns, though they should always follow facility-specific protocols for sterile technique.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PROCEDURE KIT (K926269) — FDA 510 (k) | Innolitics, Exposure Procedure Packs - General Medical, Sterile Comprehensive Set | General Medical, GENERAL MEDICAL CO. FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
General Medical Co.

Sources (1)

  • FDA 510(k) K926269 24 fields · synced Oct 6, 2026